1. Field of the Invention
This invention relates generally to devices used to inject or withdraw fluid and/or those that collect fluid samples from and/or inject fluids into patients and/or into a fluid collection, dispensing or holding device. More specifically, this invention relates to a needle assembly for such devices which have a safety system.
2. Discussion of Background Information
Prevention of needle sticks is of paramount concern in the healthcare industry because of serious and deadly risk factors associated with AIDS and other serious transmittable or communicable diseases. Typical injection and/or blood collection devices utilize a needle which can be, among other things, inserted into a patient so as to inject a substance or draw a fluid such as blood through the needle into an associated separate collection reservoir. Accidental needle sticks from currently or previously used needles can occur during the process of injection and during the fluid withdrawing process as well as during subsequent handling and disposal. Until such used medical devices are destroyed or discarded into a proper disposal collection device such as a sharps container, they remain a risk to those handling them as well as those that may come into contact with them.
Devices used for injection as well as blood sampling are well known and include a collection device sold under the trademark Vacutainer® by Becton Dickinson Corporation. The former type device includes syringes. The latter type device has a tubular syringe-like body with a needle in the front end, part of which extends back into a tubular syringe-like shell. Part of the needle extends externally for punching the skin. An evacuated collection tube with a rubber stopper is placed into the open back of the syringe-like shell with the rubber stopper against the internal end of the needle. After the skin is punctured, the collection tube is pushed forward to cause the needle to enter the evacuated tube. Vacuum helps draw blood into the collecting tube. When a sufficient sample has been obtained, the collecting tube and the stopper are simply withdrawn from the tubular shell and sent to the laboratory. This particular device has a permanently extended needle and an opening in the back for the collection tube which remains open after the collection tube is removed, leaving small droplets of blood or fluids and/or small quantities of blood or fluids and an internally exposed needle.
Medical injection devices which are used for drawing and/or injecting fluids and which may or may not include a common or standard interface are known. Such devices include: U.S. Pat. No. 6,074,373 to SUDO et al. and U.S. Pat. No. 8,012,132 to LUM et al. The disclosures of each of these documents is expressly incorporated by reference herein in their entireties.
Medical devices which are used for collecting fluid samples from patients which have quick release needle systems are also known. Such devices include: U.S. Pat. No. 5,797,490 to FUJI et al; U.S. Pat. No. 5,755,673 to KINSEY; U.S. Pat. No. 4,822,343 to BEISER; U.S. Pat. No. 4,984,580 WANAMAKER; U.S. Pat. No. Re. 38,964 to SHILLINGTON; U.S. Pat. No. 5,616,136 to SHILLINGTON et al.; U.S. Pat. No. 5,637,101 to SHILLINGTON; U.S. Pat. No. 5,117,837 to WANAMAKER et al.; U.S. Pat. No. 4,907,600 to SPENCER; U.S. Pat. No. 4,993,426 to SPENCER; U.S. Pat. No. 4,904,244 to HARSH et al.; U.S. Pat. No. 4,490,142 to SILVERN. The disclosures of each of these documents is expressly incorporated by reference herein in their entireties.
Medical devices which are used for collecting fluid samples from patients which can benefit from the improvement offered by the instant invention include: US 2010/0286558 to SCHRAGA; US 2008/0262421 to SCHRAGA; U.S. Ser. No. 12/974,908 to SCHRAGA filed on Dec. 21, 2010; and U.S. 61/480,787 to SCHRAGA filed on Apr. 29, 2011. The disclosures of each of these documents is expressly incorporated by reference herein in their entireties.
Pen needle or pre-loaded syringe devices which utilize needle safety shields are also known. These include: US 2011/0160675 to RUAN et al.; US 2011/0257603 to RUAN et al.; US 2011/0288491 to NEWMAN et al. The disclosures of each of these documents is expressly incorporated by reference herein in their entireties.
Devices having one or more features which can be used with the invention and which are disclosed in pending applications include: US 2010/0286611 to SCHRAGA; US 2010/0286558 to SCHRAGA; U.S. 61/443,958 to SCHRAGA; U.S. 61/480,787 to SCHRAGA; U.S. 61/498,133 to SCHRAGA. The disclosures of each of these documents are expressly incorporated by reference herein in their entireties.
The invention aims to improve devices of the type described above by making a needle assembly for an injection or fluid collection device which a needle safety system and/or a standard interface needle and which can also include one or more features disclosed herein and/or disclosed in one or more of the documents expressly incorporated by reference herein. The device is also believed to be as safe or safer to use and/or dispose-of than the above-noted devices.